Researcher-Professor Graduate Course in Pharmaceutical Sciences, University of Sorocaba, Sorocaba, São Paulo University of Sorocaba Piracicaba, Brazil
Background: Antiretroviral therapy (ART) is recommended for all people with HIV/AIDS and like any chronic treatment, it has adverse effects (AE). Little is known about these effects in women living with HIV/Aids.
Objectives: It’s to describe the incidence of AE of ART in women living with HIV/AIDS.
Methods: A systematic review that included randomized controlled trials with at least 12 weeks of follow-up that evaluated AE of ART in women at any age living with HIV/AIDS. Primary outcomes included the number of participants with any AE clinical and/or laboratory related or not to ART and treatment discontinuation. Secondary outcomes are severe (grade 3 and/or 4) and serious adverse events, adverse events on the female reproductive system and bone health, and the number of deaths from all causes and related to ART. Studies of pre- and post-exposure prophylaxis, pregnant or breastfeeding women, co-infection with tuberculosis, hepatitis B and C, post hoc analyses, open-label extensions without a comparator, and with ART or doses not used in clinical practice were excluded. Literature searches were performed on Medline, Embase, Cochrane Library, Epistemonikos, Lilacs, Who Index, and Clinicaltrials.gov. The team independently selected all citations, abstracts and full-text articles in pairs; conflicts were resolved by consensus or by a third reviewer. The ROB 2.0 tool (Cochrane Collaboration) was used for the risk of bias. The aggregate event incidence rate per 1000 person-years adjusted for time and loss to follow-up was estimated.
Results: A total of 21,238 studies were identified, of which 10 (2,871 women) met the eligibility criteria. Nine had a high risk of bias. Seven studies included only women. Most (80%) were not blinded. Six were from the pharmaceutical industry and three had mixed funding. The pooled analysis of all ARTs showed a mean incidence rate of treatment discontinuation of 20.78 events per 1000 person-years (95% CI 5.58-57.31), a mean ART-related discontinuation of 4.31 per 1000 person-years (95%CIr 0.13-54.72), and a mean incidence rate of ART-related clinical and laboratory AE of 341.60 events per 1000 person-years (95% CI 133.60-862.70). None of the studies evaluated AE in the female reproductive system. Only one looked at the occurrence of osteoporosis.
Conclusions: The scarcity of information on adverse events of ART specifically in women, combined with the high risk of bias in almost all existing studies, does not allow conclusions to be drawn about preferential regimens for use in women living with HIV/AIDS. New studies are needed, with adequate methodological design and scientific quality to assess AE of ART in women, to provide information to support an approach centered on people, able to timely manage the AE and ensure maximum adherence to treatment.
